Author + information
- Thomas Gleason1,
- Michael Reardon2,
- Jeffrey Popma3,
- Joon Lee4,
- Neal Kleiman5,
- Stanley Chetcuti6 and
- G. Michael Deeb7
- 1University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
- 2Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, United States
- 3Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- 4University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
- 5Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, United States
- 6University of Michigan Health Center, Ann Arbor, Michigan, United States
- 7University of Michigan Hospitals, Ann Arbor, Michigan, United States
The CoreValve US Pivotal High Risk Trial was the first randomized trial to show superiority with respect to 1-year mortality of transcatheter aortic valve replacement (TAVR) compared to surgical AVR (SAVR) among high operative mortality-risk patients. Higher all-cause mortality was also noted for SAVR at 3 years. We now report the final 5-year data for the trial.
High risk was defined as a predicted operative mortality of ≥15% but <50% for combined mortality or irreversible morbidity at 30 days. Eligible patients were stratified by recommended access site and randomized (1:1) to TAVR with the self-expanding CoreValve or SAVR. The primary endpoint was all-cause mortality at 1 year. Structural valve deterioration was based on the latest echocardiogram. VARC-1 definitions were used for secondary endpoints and major complications. Follow-up extended through 5 years.
797 patients were randomized at 45 US centers, of which 750 underwent an attempted implant (TAVR=391, SAVR=359). Mean age was 83.2±7.1 years in TAVR and 83.3±6.4 in SAVR patients. The overall mean STS score was 7.4%. The all-cause and cardiovascular mortality rates at 5 years were 55.3% and 39.7% for TAVR and 55.4% and 39.5% for SAVR, respectively. There were no differences in mortality across 9 subgroups; age, sex, BMI, STS score, LVEF, hypertension, prior CABG, PVD or diabetes. The incidence of major stroke was 12.3% for TAVR and 13.2% for SAVR. At 5 years, the EOA was 1.9±0.6 cm2 for TAVR patients and 1.7±0.6 cm2 for SAVR, and the AV gradient was 7.1±3.6 mmHg for TAVR and 10.9±5.7 mmHg for SAVR. Clinically, no valve thrombosis was observed. Severe SVD was present in 0.5% in TAVR and 1.4% in SAVR patients (p=0.27), and reintervention resulting in a new valve occurred in 1.8% of TAVR and 0.6% of SAVR patients (p=0.18).
Mid-term clinical outcomes following AVR were similar for patients treated with the transcatheter or surgical approach. PPI was higher in the TAVR patients. Severe SVD and valve reintervention were equivalently low with both approaches.
STRUCTURAL: Valvular Disease: Aortic